How to register medicines in Ethiopia with EFDA

Before you start

• Appoint a local agent or representative physically located in Ethiopia, under a signed agency agreement.
• Have your product dossier ready in the format EFDA's medicine registration guideline asks for (administrative, quality, non-clinical and clinical information).
• Make sure your manufacturing site's GMP status is documented; EFDA may inspect or rely on other authorities' inspections.

The registration steps

1. 1

   Create the application in eRIS

   EFDA only accepts registration applications online, through its Electronic Regulatory Information System (eRIS). Your local agent usually files it.

2. 2

   Submit the dossier and pay the fees

   Upload the dossier and supporting documents, and pay the service fee set by EFDA's current fee regulation.

3. 3

   Evaluation

   EFDA's guideline says applicants are notified of the evaluation result within 90 days of submission, workload permitting. Queries from EFDA pause the clock until you answer.

4. 4

   Approval and listing

   Registered products appear on EFDA's public product list in eRIS. Only then can importers apply for import permits for them.

Faster routes

Medicines prequalified by the World Health Organization can be registered through EFDA's collaborative registration procedure, which relies on WHO's assessment and is shorter than a full review.

In special situations, such as shortages or emergencies, EFDA can issue a special import permit for an unregistered product, following its special import permit guideline.

After registration: finding buyers

Registration is only the entry ticket. Your sales come from Ethiopian importers: 807 of them import medicines. Check which of them already buy your molecules on the product pages, and target importers who work with competing manufacturers.